Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

COURT DOCUMENTS SHOW GUIDANT WAITED TO WARN OF DEVICE HAZARDS

Guidant in January 2005 chose not to alert physicians about
electrical flaws in two heart defibrillators when the company knew of the defects,
allowing patients to continue being implanted with the faulty devices, according
to recently released documents.

A Texas district judge June 6 unsealed 22
court documents related to a product liability lawsuit against Guidant, including
a detailed draft of a "Dear Doctor" letter warning of potential device
failures that was never sent.

The lawsuit claims Guidant knew its Ventak
Prizm 2 defibrillators might fail and did not warn patients. Guidant has fought
to keep thousands of pages in the Texas product liability lawsuit confidential,
according to reports.

An independent panel commissioned last summer to review
Guidant's handling of its failed heart devices said the company's internal and
external communications methods "burdened the company's ability to manage
and communicate low-frequency malfunctions." The panel also found that decisions
about how to address product problems were motivated by statistical projections
by engineers rather than medical assessments by clinicians.

Problems first
surfaced in May 2005, but it became apparent that Guidant's Cardiac Rhythm Management
(CRM) group had known about the defects since at least April 2002, according to
the report.